Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes

Inhibition of dipeptidyl peptidase-4 enhances the activity of incretin hormones, improving glycemic control in subjects with type 2 diabetes. This twelve-week randomized, double-masked, placebo-controlled study assessed the efficacy and tolerability of the specific and potent oral dipeptidyl peptidase-4 inhibitor, vildagliptin (25 mg, bid, n = 70) vs. placebo (bid, n = 28) in previously diet-treated subjects with type 2 diabetes. Standardized meal tests were performed at baseline and endpoint. The betweengroup difference in adjusted mean change in HbA(1c) from baseline to endpoint was -0.6 +/- 0.2% (p = 0.0012) for the whole cohort (baseline 8.0%) and -1.2% for subjects with baseline HbA(1c) 8.0 - 9.5%. Fasting glucose and mean prandial glucose were reduced by 1.1 +/- 0.4 (p = 0.0043) and 1.9 +/- 0.5 mmol/l (p < 0.0001), respectively. The between-group differences in corrected insulin response at peak glucose and mean prandial C-peptide were + 0.06 +/- 0.02 (p = 0.0258) and + 0.10 +/- 0.03 nmol/l (p = 0.0031), respectively. Vildagliptin had no effect on fasting lipid levels or body weight. The incidence of adverse events was similar in subjects receiving placebo (71.4%) and vildagliptin (55.7%). Conclusion: monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes. Concomitant improvements in p-cell function were also observed. Subjects with higher baseline HbA(1c) levels showed greater response.